Hearing Health Care Service Access and Use
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 10/17/2018 |
| Start Date: | July 2013 |
| End Date: | June 2019 |
| Contact: | Margaret I Wallhagen, PhD, RN |
| Email: | meg.wallhagen@ucsf.edu |
| Phone: | 415 376 4965 |
Primary Care Intervention Promoting Hearing Health Care Service Access and Use
Hearing loss screening rates in for older persons in primary care clinics are very low even
though hearing loss is relatively common for older persons. When diagnosed with hearing loss
older persons are often reluctant to follow through. This study involves a prospective
controlled trial comparing the effectiveness of three primary care based protocols for older
adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to
and use of hearing health care services. The protocols will compare: 1) screening only
(standard care control); 2) screening plus an illustrated educational brochure; and 3)
screening plus an in-person educational intervention and an illustrated educational brochure.
Screening will be done by primary care personnel. Participants will be tracked for 8 months
to assess outcomes.
though hearing loss is relatively common for older persons. When diagnosed with hearing loss
older persons are often reluctant to follow through. This study involves a prospective
controlled trial comparing the effectiveness of three primary care based protocols for older
adults ≥ 60 who screen positive for possible hearing loss in promoting subsequent access to
and use of hearing health care services. The protocols will compare: 1) screening only
(standard care control); 2) screening plus an illustrated educational brochure; and 3)
screening plus an in-person educational intervention and an illustrated educational brochure.
Screening will be done by primary care personnel. Participants will be tracked for 8 months
to assess outcomes.
The purpose of this study is to evaluate the extent to which hearing health outcomes are
improved when patients are screened for hearing loss and provided an educational brochure or
screened and provided the brochure plus an educational segment emphasizing points in the
brochure versus a standard screening only protocol. These procedures are non-invasive.
Hearing loss screening is part of basic health evaluations for older persons, brochures are
commonly handed out for a variety of health conditions, and providing patient education is
common practice.
At all sites our study research nurse will train clinic staff, contact patients who have
indicated they are interested in taking part, obtain informed consent, administer baseline
and follow-up questionnaires, and ensure that those completing the two follow-ups receive
their gift cards. No information from clinic medical records will be obtained.
Aims:
1. Evaluate the extent to which hearing health outcomes are improved when patients are
screened for hearing loss and provided an educational brochure or screened and provided
the brochure plus an educational segment emphasizing points in the brochure versus a
standard screening only protocol..
2. Examine hearing health outcomes by patient and clinic characteristics.
3. Compare any observed gains in outcomes against the estimated staff time to administer
either the brochure or the brochure plus the educational segment.
The three primary outcomes involve comparing the differential impacts of adding an
illustrated educational brochure or adding both a brochure and a brief educational segment
over screening only. These three outcomes are whether the participant went to see a hearing
specialist for an evaluation, whether a hearing or other assistive listening device was
obtained if recommended, and whether the device if obtained was being used. Other outcomes
include the number of hours a day participants who received assistive devices actually wear
them, the number of changes participants have made to improve communication other than
obtaining an assistive device, and the extent to which their hearing related quality of life
improves.
The primary care clinics taking part in our study already do some screening for hearing loss
but often screening is not perceived as leading to better outcomes. The clinics are
interested in the opportunity to participate in a project that will assess how effective
screening is when combined with additional educational material. All consenting and data
collection will be done by our study's Research Nurse.
Specific procedures are:
1. Older patients coming into the clinic for a medical appointment and who are not wearing
hearing aids will be screened by intake personnel (usually a medical assistant or office
nurse) for hearing loss using a direct question ("Do you have any difficulty hearing?")
and a finger rub test (the finger rub protocol is attached). When either or both of
these tests indicate possible hearing loss, intake personnel will tell the patient that
their health care provider will be informed and then ask them if they are interested in
taking part in a study of hearing loss. Those who express an interest will be asked to
fill out contact information on a card for transmission to the study's Research Nurse.
They will also be given a flyer describing the study and two copies of the consent to
take with them to review and discuss with the study's research nurse. A stamped return
envelope will be included for mailing the signed consent after discussing the study with
the Research Nurse. The envelope will have the study address both on the front and in
the space for the return address in order to protect patient confidentiality.
One of three protocols will then occur for those indicating an interest in the study:
- For the first 28 patients the intake personnel will take no further action other
than to provide the screening results to the patient's health care provider.
- For the next 28 patients the intake personnel will hand them the brochure For the
last 28 patients the intake personnel will hand them the brochure and then ask if
it is all right with them if he/she goes over some points in the brochure.
2. Training for the finger rub and what to do during the three protocols will be conducted
by the study's Research Nurse.
3. The health care provider that the patient sees will follow his or her usual procedures
for handling a patient with possible hearing loss. This usually involves checking the
ears for wax buildup, further discussion about the possible extent of the loss, and
referral to a hearing specialist if warranted.
4. The Research Nurse will come by the clinics regularly to pick up the contact cards and
respond to any questions that medical assistants or other clinic staff may have.
5. The Research Nurse will then contact potential participants to explain the study, review
the consent they took home, ask those still interested in taking part in the study to
sign one copy of the consent and place it in the provided envelope for mailing, and
administer the baseline questionnaire. She will explain that there will be two follow-up
contacts at 4 and 8 months. If participants can hear well enough to do the interviewing
over the telephone it will be used for all contact between the Research Nurse and
participants. The informed consent will include a self-addressed envelope for mailing
the signed copy to the Research Nurse. If participants do not feel they can hear well
enough to talk with the Research Nurse over the telephone, all consenting and
interviewing will be done at a place of their own choosing.
6. At the end of the 8-month follow-up, participants from the first two protocol groups
will be given the same educational materials (brochure and/or verbal educational
protocol) by the study Research Nurse that they would have received had they been in the
third protocol group. Thus by the end of the study all participants will have received
the brochure and the educational intervention.
improved when patients are screened for hearing loss and provided an educational brochure or
screened and provided the brochure plus an educational segment emphasizing points in the
brochure versus a standard screening only protocol. These procedures are non-invasive.
Hearing loss screening is part of basic health evaluations for older persons, brochures are
commonly handed out for a variety of health conditions, and providing patient education is
common practice.
At all sites our study research nurse will train clinic staff, contact patients who have
indicated they are interested in taking part, obtain informed consent, administer baseline
and follow-up questionnaires, and ensure that those completing the two follow-ups receive
their gift cards. No information from clinic medical records will be obtained.
Aims:
1. Evaluate the extent to which hearing health outcomes are improved when patients are
screened for hearing loss and provided an educational brochure or screened and provided
the brochure plus an educational segment emphasizing points in the brochure versus a
standard screening only protocol..
2. Examine hearing health outcomes by patient and clinic characteristics.
3. Compare any observed gains in outcomes against the estimated staff time to administer
either the brochure or the brochure plus the educational segment.
The three primary outcomes involve comparing the differential impacts of adding an
illustrated educational brochure or adding both a brochure and a brief educational segment
over screening only. These three outcomes are whether the participant went to see a hearing
specialist for an evaluation, whether a hearing or other assistive listening device was
obtained if recommended, and whether the device if obtained was being used. Other outcomes
include the number of hours a day participants who received assistive devices actually wear
them, the number of changes participants have made to improve communication other than
obtaining an assistive device, and the extent to which their hearing related quality of life
improves.
The primary care clinics taking part in our study already do some screening for hearing loss
but often screening is not perceived as leading to better outcomes. The clinics are
interested in the opportunity to participate in a project that will assess how effective
screening is when combined with additional educational material. All consenting and data
collection will be done by our study's Research Nurse.
Specific procedures are:
1. Older patients coming into the clinic for a medical appointment and who are not wearing
hearing aids will be screened by intake personnel (usually a medical assistant or office
nurse) for hearing loss using a direct question ("Do you have any difficulty hearing?")
and a finger rub test (the finger rub protocol is attached). When either or both of
these tests indicate possible hearing loss, intake personnel will tell the patient that
their health care provider will be informed and then ask them if they are interested in
taking part in a study of hearing loss. Those who express an interest will be asked to
fill out contact information on a card for transmission to the study's Research Nurse.
They will also be given a flyer describing the study and two copies of the consent to
take with them to review and discuss with the study's research nurse. A stamped return
envelope will be included for mailing the signed consent after discussing the study with
the Research Nurse. The envelope will have the study address both on the front and in
the space for the return address in order to protect patient confidentiality.
One of three protocols will then occur for those indicating an interest in the study:
- For the first 28 patients the intake personnel will take no further action other
than to provide the screening results to the patient's health care provider.
- For the next 28 patients the intake personnel will hand them the brochure For the
last 28 patients the intake personnel will hand them the brochure and then ask if
it is all right with them if he/she goes over some points in the brochure.
2. Training for the finger rub and what to do during the three protocols will be conducted
by the study's Research Nurse.
3. The health care provider that the patient sees will follow his or her usual procedures
for handling a patient with possible hearing loss. This usually involves checking the
ears for wax buildup, further discussion about the possible extent of the loss, and
referral to a hearing specialist if warranted.
4. The Research Nurse will come by the clinics regularly to pick up the contact cards and
respond to any questions that medical assistants or other clinic staff may have.
5. The Research Nurse will then contact potential participants to explain the study, review
the consent they took home, ask those still interested in taking part in the study to
sign one copy of the consent and place it in the provided envelope for mailing, and
administer the baseline questionnaire. She will explain that there will be two follow-up
contacts at 4 and 8 months. If participants can hear well enough to do the interviewing
over the telephone it will be used for all contact between the Research Nurse and
participants. The informed consent will include a self-addressed envelope for mailing
the signed copy to the Research Nurse. If participants do not feel they can hear well
enough to talk with the Research Nurse over the telephone, all consenting and
interviewing will be done at a place of their own choosing.
6. At the end of the 8-month follow-up, participants from the first two protocol groups
will be given the same educational materials (brochure and/or verbal educational
protocol) by the study Research Nurse that they would have received had they been in the
third protocol group. Thus by the end of the study all participants will have received
the brochure and the educational intervention.
Inclusion Criteria:
- Age 60 or older
- Not currently wearing a hearing aid
- Cognitively capable of giving informed consent
- Able to speak and understand English
- No concurrent health problem that would limit participation
- Screen positive for hearing loss using single question and/or finger rub
Exclusion Criteria:
- Age 59 or less
- Currently wearing a hearing aid
- Cognitively impaired or not cognitively capable of giving informed consent
- Unable to speak and understand English
- Has a concurrent health condition that limits participation
- Does not screen positive for hearing loss
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Margaret I Wallhagen, PhD, RN
Phone: 415-476-4965
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